Safety and Effectiveness of NicVAX in Treating Nicotine Dependent Individuals

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218413
First received: September 16, 2005
Last updated: November 3, 2008
Last verified: November 2008
  Purpose

Nicotine is highly addictive and many individuals are unable to quit smoking even with treatment. The purpose of this study is to determine the effectiveness of various doses of NicVAX in treating nicotine dependent individuals.


Condition Intervention Phase
Smoking Cessation
Tobacco Use Cessation
Biological: NicVAX
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Assess Safety and Immunogenicity of Five Doses of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) Administered to Smokers

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Anti-nicotine Antibody concentrations [ Time Frame: 19 time points from Day 0 to 365 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Smoking cessation [ Time Frame: periods of 2 weeks, 4 weeks, or 12 weeks duration ] [ Designated as safety issue: No ]
  • Fagerstrom Test for Nicotine Dependence [ Time Frame: 7 time points from Day 0 to 365 ] [ Designated as safety issue: No ]
  • Safety: vaccine reactogenicity [ Time Frame: 7 days after each dose ] [ Designated as safety issue: Yes ]
  • Safety: adverse events [ Time Frame: Day 0-365 ] [ Designated as safety issue: Yes ]

Enrollment: 51
Study Start Date: October 2004
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: NicVAX
100 μg, Formulation A, on Days 0, 21, 42, 91 & 182
Other Name: 3'-aminomethylnicotine-rEPA conjugate vaccine
Experimental: 2 Biological: NicVAX
200 μg, Formulation A, on Days 0, 21, 42, 91 & 182
Other Name: 3'-aminomethylnicotine-rEPA conjugate vaccine
Experimental: 3 Biological: NicVAX
200 μg, Formulation B, on Days 0, 21, 42m 91 & 182
Other Name: 3'-aminomethylnicotine-rEPA conjugate vaccine
Experimental: 4 Biological: NicVAX
300 μg, Formulation B, on Days 0, 21, 42, 91 & 182
Other Name: 3'-aminomethylnicotine-rEPA conjugate vaccine
Experimental: 5 Biological: NicVAX
400 μg, Formulation B, on Days 0, 21, 42, 91 & 182
Other Name: 3'-aminomethylnicotine-rEPA conjugate vaccine

Detailed Description:

Tobacco use is the single leading preventable cause of death in the United States. Nicotine is an alkaloid that is derived from the tobacco plant responsible for the psychoactive and addictive effects of smoking. Immunotherapy may be useful in preventing and treating nicotine dependent individuals. NicVAX is a nicotine vaccine, a type of immunotherapy that may be effective in smoking cessation and preventing relapse to nicotine. The purpose of this study is to evaluate the safety and efficacy of various dosing levels and dosing frequencies of NicVAX in treating nicotine dependent individuals.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current smoker
  • Good general health, including mental health
  • Alveolar carbon monoxide level greater than or equal to 10 ppm

Exclusion Criteria:

  • Prior exposure to NicVAX
  • Known allergy to any of the components of NicVAX
  • Use of any smoking cessation aide
  • Pregnant or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218413

Locations
Netherlands
University of Maastricht
Maastricht, Netherlands, 6229 HA
Sponsors and Collaborators
Nabi Biopharmaceuticals
Investigators
Principal Investigator: Gary Horwith Nabi Biopharmaceuticals
Principal Investigator: Arjen De Vos, MD, PhD Nabi Biopharmaceuticals
  More Information

No publications provided

Responsible Party: Arjen DeVos/ Senior Director, Medical Affairs and Clinical Research, Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00218413     History of Changes
Other Study ID Numbers: NIDA-17894-2, Nabi-4505, R01-17894-2, DPMC
Study First Received: September 16, 2005
Last Updated: November 3, 2008
Health Authority: Netherlands: Independent Ethics Committee
United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Vaccine
Immunogenicity
Randomized Controlled Trial
Addiction

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014